– Ophthotech’s Ex-US Agreement with Novartis for Fovista®
Remains Unchanged –
– Ophthotech Continues the Ownership of Sole US Rights for Fovista®
– Ophthotech to Host Conference Call Today at 8:30 a.m. Eastern Time –
NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (Nasdaq:OPHT) announced today that Genentech, a
Roche wholly-owned subsidiary, has elected to exercise its option to
participate in the financial arrangements relating to Novartis’ rights
under the Ophthotech/Novartis ex-US agreement for Fovista®
(pegpleranib) to treat wet age-related macular degeneration (AMD).
Roche’s option originates from a pre-existing agreement between Roche
and Novartis. Ophthotech’s agreement with Novartis and its financial
terms remain unchanged including potential payments to Ophthotech of
over $1 billion in upfront and milestone payments, and future royalties
on ex-US Fovista® sales. Ophthotech continues to retain sole
rights to Fovista® in the United States.
“We are indeed pleased by what is potentially an unprecedented
arrangement between two of the leading pharmaceutical companies for a
single product in the ex-US territory, while the US rights are retained
by the innovator biotech company,” stated David R. Guyer, M.D., Chief
Executive Officer and Chairman of the Board of Ophthotech. “We believe
that this arrangement further validates Fovista®’s novel
technology, reflects the industry’s need for the next-generation
therapeutic option for wet AMD, and also highlights the industry’s
acknowledgement of the large commercial opportunity resulting from the
significant unmet need in the large and expanding market for wet AMD.
Our Fovista® ex-US agreement with Novartis remains unchanged.
We continue to be very impressed with the extensive resources and
tremendous commitment that Novartis is putting into the Fovista®
program. Additionally, we are excited about the recent completion of
patient recruitment in two of the Phase 3 trials of Fovista®.”
In October 2015, Ophthotech announced the completion of patient
recruitment for its second Phase 3 trial of Fovista® in
combination with Lucentis® (ranibizumab) for the treatment of
wet AMD. The Company expects to announce initial, topline data from both
Phase 3 trials of Fovista® in combination with Lucentis®
in the fourth quarter of 2016. A third Phase 3 trial, which is
investigating Fovista® in combination with other anti-VEGF
agents, continues to enroll patients with recruitment on track.
The Company believes that Fovista® is the most advanced
anti-PDGF agent in development for the treatment of wet AMD and, if
approved, is expected to be first to market in this class of novel
therapies for wet AMD.
Background of the Fovista®
The Ophthotech / Novartis ex-US licensing and commercialization
agreement went into effect on May 19, 2014, and remains unchanged.
Previously announced terms of the agreement include:
Ophthotech granted Novartis exclusive rights to commercialize
Ophthotech’s lead product candidate, Fovista®, in
markets outside the United States while Ophthotech retains sole rights
to commercialize Fovista® in the United States.
Ophthotech continues to lead the global Fovista® Phase
3 wet AMD pivotal clinical program. Ophthotech continues its lead role
in the potential registration of Fovista® in the
United States, while Ophthotech and Novartis will collaborate to seek
regulatory approvals outside the United States.
This collaboration continues Ophthotech’s Fovista®
development strategy to remain agnostic with respect to the choice of
the anti-VEGF agent administered in combination with Fovista®.
Separate injections of the anti-VEGF agent and Fovista® would
allow physicians to choose their preferred anti-VEGF agent for the
combination therapy. The collaboration also provides for the potential
development of a fixed combination delivery of a co-formulation of
Fovista® with a Novartis proprietary anti-VEGF
product which would result in additional flexibility for physicians.
Novartis is seeking to develop and commercialize alternative
innovative delivery technologies such as a Fovista®
pre-filled syringe as part of this collaboration.
Previously announced financial terms of the agreement remain unchanged
Ophthotech to potentially receive over $1 billion in upfront and
milestone payments during the course of the collaboration, not
including future royalties.
Ophthotech received a total of $300 million in upfront fees and
enrollment milestone payments. These fees received from Novartis
consisted of a $200 million upfront fee upon the execution of the
agreement in May of 2014 and a $50 million enrollment-based
milestone fee achieved in September 2014 and a second $50 million
enrollment-based milestone fee achieved in March 2015. An
additional $30 million in potential enrollment-based milestone
payments remain available under the agreement.
Ophthotech is eligible to receive contingent future ex-US
marketing approval milestones totaling up to $300 million and
ex-US sales milestones up to $400 million.
- Ophthotech received a total of $300 million in upfront fees and
Ophthotech is entitled to receive royalties on ex-US Fovista®
Conference Call/Web Cast Information
Ophthotech will host a conference call/audio webcast to discuss this
announcement. The call is scheduled for November 17, 2015 at 8:30 a.m.
Eastern Time. To participate in this conference call, dial 888-364-3108
(USA) or 719-457-2661 (International), passcode 5187947. A live,
listen-only audio webcast of the conference call can be accessed on the
Investor Relations section of the Ophthotech website at: www.ophthotech.com.
A replay will be available approximately two hours following the live
call for two weeks. The replay number is 888-203-1112 (USA Toll Free),
passcode 5187947. The audio webcast can be accessed at: www.ophthotech.com.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics to treat back of the eye diseases,
with a focus on developing innovative therapies for age-related macular
degeneration (AMD). Ophthotech’s most advanced product candidate, Fovista®
anti-PDGF therapy, is in Phase 3 clinical trials for use in combination
with anti-VEGF therapy that represents the current standard of care for
the treatment of wet AMD. Ophthotech’s second product candidate, Zimura®,
an inhibitor of complement factor C5, is being developed for the
treatment of geographic atrophy, a form of dry AMD. For more
information, please visit www.ophthotech.com.
Any statements in this press release about Ophthotech’s future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech’s strategy, future operations and future
expectations and plans and prospects for Ophthotech, and any other
statements containing the words “anticipate,” “believe,” “estimate,”
“expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions. In this press release, Ophthotech’s
forward looking statements include statements about the timing and
progress of the Fovista® Phase 3 clinical program and Fovista®
expansion studies, including the timing of completion of enrollment for
these trials, the timing of obtaining initial, topline data or interim
data from these trials, the timing of seeking marketing approval for
Fovista®, the potential of Fovista® as a wet AMD combination therapy,
and the initiation of additional trials for Fovista® and Zimura®.
Such forward-looking statements involve substantial risks and
uncertainties that could cause Ophthotech’s clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, those
related to the initiation and conduct of clinical trials, availability
of data from clinical trials and expectations for regulatory approvals
or other actions and other factors discussed in the “Risk Factors”
section contained in the quarterly and annual reports that Ophthotech
files with the SEC. Any forward-looking statements represent
Ophthotech’s views only as of the date of this press release. Ophthotech
anticipates that subsequent events and developments will cause its views
to change. While Ophthotech may elect to update these
forward-looking statements at some point in the future, Ophthotech
specifically disclaims any obligation to do so except as required by law.
Vice President, Investor Relations and Corporate
LLC on behalf of Ophthotech Corporation